tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control

October 2, 2014 updated by: MARCELO T. BERLIM, Douglas Mental Health University Institute

Modulating Decision-Making and Impulse Control With Transcranial Direct Current Stimulation (tDCS) Over the Orbitofrontal Cortex (OFC): A Randomized and Sham-Controlled Study

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy volunteers. We hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance decision-making and impulse control. For this study we will enroll 45 healthy individuals aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. Assessments will be carried out before and after a single 30-minute tDCS session.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4H1R3
        • Neuromodulation Research Clinic, Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women aged 18 to 60 years

Exclusion Criteria:

  • Presence any psychiatric and/or neurological illness
  • Psychoactive substance abuse/dependence in the past 6 months
  • Current use of medication(s) that might influence cognition and/or affective status
  • Presence of an uncontrolled medical disease (e.g., cardiovascular, renal)
  • Pregnancy and/or lactation
  • Specific contraindication for tDCS (e.g., metallic head implant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tDCS
Device: Transcranial Direct Current Stimulation
Anode placed over the OFC or the DLPFC and cathode placed over the occipital region
Other Names:
  • tDCS, Brain Polarization
Experimental: Left OFC Group
Anode applied to the left OFC and cathode applied to the right OFC
Device: Transcranial Direct Current Stimulation
Anode placed over the OFC or the DLPFC and cathode placed over the occipital region
Other Names:
  • tDCS, Brain Polarization
Experimental: Right OFC Group
Anode applied to the right OFC and cathode applied to the left OFC
Device: Transcranial Direct Current Stimulation
Anode placed over the OFC or the DLPFC and cathode placed over the occipital region
Other Names:
  • tDCS, Brain Polarization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the net score of the Iowa Gambling Task
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session
Change in the number of risky choices in the Game of Dice Task
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session
Change in the number of commission errors in the Continuous Performance Task
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session
Change in the interference index in the Stroop Color-Word Test
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session
Change in the stop-signal reaction time in the Stop-Signal Task
Time Frame: Before and after a 30-minute tDCS session
Before and after a 30-minute tDCS session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Douglas Mental Health University Institute

Investigators

  • Principal Investigator: Marcelo Berlim, MD, MSc, Neuromodulation Research Clinic, Douglas Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB-11/42
  • 2012 YIA (Other Grant/Funding Number: Brain & Behavior Research Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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